HHS' inspector general's office asked the governing boards and top management of pharmaceutical companies to make formal, explicit commitments to ethical behavior, in the agency's long-awaited compliance guidance for the industry. The 39-page guidance identified three major areas in which drugmakers are most likely to cross the line: inaccurate or inadequate payment data submitted to state and federal agencies; marketing tactics that amount to kickbacks, or other improper remuneration; and violations of drug sample laws. Among other elements, compliance efforts should include at a minimum: written standards of conduct, designation of a compliance officer or committee, education and training, protection for whistleblowers and internal audits.
The guidance, published in draft form in October, is meant to give companies a benchmark against which to evaluate their efforts and is not legally binding. In recent years, pharmaceutical companies have been the target of numerous whistleblower lawsuits and criminal investigations alleging fraud and kickbacks. Two weeks ago, Bayer AG and GlaxoSmithKline paid about $344 million combined to settle alleged violations of Medicaid rebate law. In 2001, TAP Pharmaceutical Products paid more than $875 million to settle civil and criminal fraud charges regarding the marketing of a cancer drug. The inspector general's guidance was discussed today at the Health Care Compliance Association's meeting in New Orleans. -- by Mark Taylor